Blood tests significantly underestimated lead levels, FDA and CDC warn

Certain tests to detect lead poisoning could produce faulty results, regulators warn

And the FDA says it's aggressively investigating why these tests can give inaccurate results.

Officials from the Food and Drug Administration and the Centers for Disease Control and Prevention warn consumers that some blood tests may have "significantly" underestimated the lead levels present in samples.

Healthcare professionals and public health laboratories should discontinue using Magellan's LeadCare System Testing System with venous blood samples, due to concerns about inaccurately low results, said the FDA in a safety communication.

The blood tests were made by Magellan Diagnostics and it's the only FDA-approved test used in most doctor's offices, the FDA said.

Between the beginning of 2014 to today, officials say, an estimated 8 million blood lead tests have been run using the Magellan systems, and the majority of those were for capillary blood from finger or heel sticks. CDC recommends retesting all children under six who had their blood drawn from a vein and had a blood lead result of less than 10 µg/deciliter with a Magellan Diagnostics lead test.

The letter went on to urge that the tests "should not be submitted to the CT DPH for disease reporting purposes". Shuren added that while the Magellan LeadCare system is the only FDA-cleared test specifically for lead and the primary source of lead testing for doctor's offices and clinics in the US, it is "not the only method of testing", he said.

Patrick Breysse, director of the CDC's National Center for Environmental Health, said, "We understand that parents of children and others affected by this problem will be concerned about what this means for their health". Those kinds of blood draws are usually done in labs.

Magellan CEO Amy Winslow said the company does not expect a big demand for retesting because the warning does not cover capillary results.

"At this time we believe most people will not be affected by this issue", Shuren said on a conference call with reporters. Pregnant and nursing women should likewise get rechecked, and other adults who might have a reason to worry about lead exposure should talk to their doctors.

FDA's diagnostic review team first learned of the potentially inaccurate results when reviewing a 510 (k) submission for a new version of the LeadCare system earlier this year, Shuren said.

However, on April 28, Magellan notified customers they should no longer use the blood collection tubes, and that they should also discontinue the 24-hour incubation method. Higher lead levels can cause damage to the kidneys and nervous system, while very high levels can be fatal, the Mayo Clinic states.

Lead poisoning is especially unsafe to babies and young children. Low-level lead exposure, even at blood lead concentrations below 5 g/dL, can increase the risk of intellectual and academic disabilities in children, and is linked to higher rates of behavioral disorders such as hyperactivity and attention deficits, and lower birth weight.

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